Child Health Update

Antibiotic therapy for children

with acute otitis media
Teeranai Sakulchit MD  Ran D. Goldman MD FRCPC

Abstract
Question  Acute otitis media is one of the most common infections in childhood. Routine prescription of
antibiotics has led to adverse events and bacterial resistance to antibiotics. I have heard that “watchful
waiting” is a good strategy to reduce this potential problem in children older than 6 months of age. Should I
apply this strategy in my clinical practice?

Answer  Watchful waiting can be applied in selected children with nonsevere acute otitis media by
withholding antibiotics and observing the child for clinical improvement. Antibiotics should be promptly
provided if the child’s infection worsens or fails to improve within 24 to 48 hours. Guidelines and most
ongoing studies support these recommendations. Correct choice of regimen, dose, frequency, and length of
treatment are all important.

A cute otitis media (AOM) is an acute inflammation of

the middle ear caused by viral (such as respiratory
syncytial virus, rhinovirus, influenza viruses, and adeno-
viruses) or bacterial (such as Streptococcus pneumoniae,
nontypeable Haemophilus influenzae, and Moraxella
catarrhalis) infections.1,2 Preceding viral upper respira-
tory tract infection leads to eustachian tube obstruction;
fluid stasis and colonization of pathogens then occurs
within the middle ear. Young children are susceptible to
AOM owing to their shorter and more horizontal eusta-
chian tubes, through which pathogens ascend from the
nasopharynx to the middle ear.3,4
The estimated incidence of AOM worldwide is 11%
(709 million cases each year), and half of cases occur in
children younger than 5 years of age.5 After introduction
of the heptavalent pneumococcal conjugate vaccine in
the United States in 2000, the national prevalence rates
of hospital admission for those younger than 21 years of
age with AOM and its complications decreased from 3.9
to 2.6 per 100 000 persons (P < .0001), especially in children
younger than 2 years of age (from 13.6 to 5.5 per 100 000
persons between 2000 and 2012, respectively; P < .0001).6
Signs and symptoms of AOM include otalgia as well
as tugging, rubbing, or holding of the ear. Fever, irrita-
bility, and symptoms of upper respiratory tract infection
such as cough or rhinorrhea might also be observed.1,4
According to the 2016 Canadian Paediatric Society and
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2013 American Academy of Pediatrics guidelines, AOM
can be diagnosed if there is middle ear effusion with
signs of middle ear inflammation on otoscopic exam-
ination, such as moderate to severe tympanic mem-
brane (TM) bulging, new onset of otorrhea not caused
by otitis externa, or mild bulging of the TM associated
with recent onset of otalgia (less than 48 hours) or ery-
thema. 7,8 Treatment of AOM includes administration
of antipyretics and analgesics.7,8 Antimicrobial therapy
should be considered in selected patients.7,8
Role of antibiotics
The 2016 Canadian Paediatric Society guidelines suggest
that for children older than 6 months of age (who are
immunocompetent and without craniofacial abnormali-
ties, tympanostomy tubes, or recurrent AOM), antibiotic
administration is recommended for those with perfo-
rated tympanic membrane with purulent drainage and
those with middle-ear effusion and a bulging TM who
are moderately or severely ill (ie, with high fever [≥ 39°C],
those with moderate to severe systemic illness or severe
otalgia, or those who have already been severely ill for
48 hours). For children who are mildly ill, alert, with low
grade fever (< 39°C) responding to antipyretics and mild
otalgia and mild or moderate bulging of the TM, watch-
ful waiting can be advised. Antibiotics or a prescription
to be filled if symptoms worsen or do not improve in 24
to 48 hours can be provided.7
Amoxicillin is the drug of choice if antibiotics are
required, given as 45 to 60 mg/kg per day in 3 divided
doses; if a twice-daily dosing regimen is used, higher
total daily doses of 75 to 90 mg/kg per day are required.
Amoxicillin-clavulanate should be considered if there is
concurrent purulent conjunctivitis, a history of amoxicillin

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Child Health Update
treatment within the previous 30 days, relapse of a recent
infection, or nonresponse to amoxicillin. Consider a second-
generation (cefprozil or cefuroxime) or third-generation
cephalosporin if the child has a nonsevere allergic reaction
to amoxicillin or penicillin. Other regimens such as macro-
lides or clindamycin can be used but have limited efficacy.
If oral medication is not tolerated, intramuscular or intra-
venous ceftriaxone might be appropriate. Consider 10 days’
duration of antibiotics in children younger than 2 years of
age and those with recurrent AOM or AOM with perforated
TMs; 5 days of antibiotics might be appropriate for children
2 years of age or older with uncomplicated disease.
Antibiotics vs placebo or watchful waiting
Two recent meta-analyses reported similar results in
relation to the limited role of antibiotics.9,10 Venekamp
et al 9 included 13 randomized controlled trials from
high-income countries with approximately 3400 chil-
dren receiving either antibiotics (ampicillin, amoxicillin,
amoxicillin-clavulanate, and others) or placebo. Most
(60%) children reported less pain with either antibiot-
ics or placebo. Antibiotics did not reduce pain in the
first 24 hours (risk ratio [RR] = 0.89, 95% CI 0.78 to 1.01);
they had only a slight effect on pain in the following
days compared with placebo (at 2 to 3 days, RR = 0.7,
95% CI 0.57 to 0.86, number needed to treat for an addi-
tional beneficial outcome [NNT] = 20; at 4 to 7 days,
RR = 0.76, 95% CI 0.63 to 0.91, NNT = 16; and at 10 to 12
days, RR = 0.33, 95% CI 0.17 to 0.66, NNT = 7). Antibiotics
were associated with fewer abnormal tympanometry
findings at 2 to 4 weeks (RR = 0.82, 95% CI 0.74 to 0.90,
NNT = 11) and at 6 to 8 weeks (RR = 0.88, 95% CI 0.78 to
1.00, NNT = 16). At 3 months, however, no difference in
the number of children with abnormal tympanometry
findings was noted (RR = 0.97, 95% CI 0.76 to 1.24).
Severe complications such as mastoiditis and menin-
gitis were rare and not different between groups. Adverse
events related to antibiotics (such as vomiting, diarrhea,
and rash) occurred, as expected, more in the antibiotic
group (RR = 1.38, 95% CI 1.19 to 1.59, number needed to
treat for an additional harmful outcome of 14).
When comparing antibiotics given immediately with
waiting with “expectant observation,” 5 trials with 1150
children suggested no difference in pain at 3 to 7 days
of illness (RR = 0.75, 95% CI 0.50 to 1.12).9 Further, no
differences were found between groups in the number
of children with abnormal tympanometry findings at 4
weeks (RR = 1.03, 95% CI 0.78 to 1.35) or AOM recur-
rence (RR = 1.41, 95% CI 0.74 to 2.69). Neither TM perfora-
tion nor serious complications occurred in either group.
Immediate antibiotics were associated with more adverse
events compared with “expectant observation” (RR = 1.71,
95% CI 1.24 to 2.36; number needed to harm of 9).
Results from a meta-analysis of individual patient
data that included 1643 children suggested antibiotics
686  Canadian Family Physician • Le Médecin de famille canadien
were beneficial in children younger than 2 years of age
with bilateral AOM or AOM with otorrhea.9
In a prospective study including Finnish children 6 to
35 months of age with AOM, 53 children received placebo
but were changed to antibiotics after a watchful wait-
ing period if no improvement was noted during follow-
up, and 161 children received amoxicillin-clavulanate
at diagnosis for 7 days.11 Improvement was observed in
91% and 96% of children, respectively (P = .15). Children
in the delayed antibiotics group had a longer time to nor-
malization of symptoms and otoscopic findings (while on
watchful waiting). Adverse events were similar in both
groups. Other effects to consider in the watchful wait-
ing period are the increased time with pain and delay in
returning to regular activities.
Overall, delayed administration of antibiotics in children
with AOM might not affect their clinical condition with the
exception of social and economic effects for the family.
Type, frequency, and duration of antibiotics
A US-based study reported amoxicillin-clavulanate
(80 mg/kg per day for 10 days) to be more effective
than cefdinir (14 mg/kg per day for 5 days) in treat-
ing 330 children 6 to 24 months of age with AOM. The
amoxicillin-clavulanate group had an 86.5% cure rate
(resolution of signs and symptoms of AOM), which was
significantly better than the 71% cure rate in the cefdinir
group (P = .001).12 Further, a logistic regression model
suggested that the odds of cure with cefdinir signifi-
cantly declined with age (P = .01).
Thanaviratananich et al13 included 5 trials in a meta-
analysis evaluating the frequency of antibiotics prescribed
to 1600 children younger than 12 years of age and con-
cluded that the efficacy of 1 to 2 daily doses of amoxicil-
lin (with or without clavulanate) was comparable to that
of 3 daily doses. Clinical cure at the end of 7 to 15 days
of therapy (RR = 1.03, 95% CI 0.99 to 1.07), during therapy
(RR = 1.06, 95% CI 0.85 to 1.33), and at follow-up at 1 to
3 months after treatment (RR = 1.02, 95% CI 0.95 to 1.09);
recurrent AOM (RR = 1.21, 95% CI 0.52 to 2.81); the com-
pliance rate (RR = 1.04, 95% CI 0.98 to 1.10); and overall
adverse events (RR = 0.92, 95% CI 0.52 to 1.63) were not
significantly different between the group receiving 1 or 2
daily doses and the group receiving 3 daily doses.
An American study reported that reduction in duration
of amoxicillin-clavulanate from 10 to 5 days followed by
placebo for 5 days resulted in less favourable outcomes
among 520 children 6 to 23 months of age with AOM.14
Clinical failure (34% vs 16%; 95% CI 9% to 25%) and mean
symptom scores (higher scores indicated more severe
symptoms) at day 6 to 14 (1.61 vs 1.34; P = .07) and at
day 12 to 14 (1.89 vs 1.20; P = .001) were significantly
different in the 5-day group compared with that in 10-day
group. There were fewer children whose symptom scores
decreased more than 50% from baseline to the end
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treatment in the 5-day compared with the 10-day group
(80% vs 91%, respectively; P = .003). There were no signifi-
cant differences in the rate of recurrence, adverse events,
or nasopharyngeal colonization after treatment between
groups. A 10-day course is preferable to a 5-day course.
Complications of AOM
Acute mastoiditis as a complication of AOM was not
more common in children who received delayed antibi-
otics when compared with those who received immedi-
ate antibiotics. A prospective observational study from
Israel reviewed the medical records of children younger
than 14 years of age with acute mastoiditis admitted to
8 hospitals.15 In 512 children, 216 (42%) had previous
AOM; 73% received immediate antibiotics (amoxicillin)
and 27% had delayed antibiotics. The rate of recur-
rent AOM was much higher in those treated immedi-
ately (29% vs 8.7%, respectively; P = .0021). Admission
rates were similar (37% vs 29%; P = .28). Adjusted logistic
regression suggested a higher risk of mastoiditis surgery
in those treated immediately (RR = 3.2, 95% CI 1.4 to 7.0).
However, this is likely owing to illness severity.
Conclusion
Watchful waiting can be used in children with mild or
moderate disease and it might not increase the risk of
subsequent acute mastoiditis. High-dose amoxicillin is
the drug of choice in Canada as first-line therapy. Ten
days’ duration of antibiotics is more effective than a
5-day course for children 6 to 23 months of age. 
Competing interests
None declared
Correspondence
Dr Ran D. Goldman; e-mail rgoldman@cw.bc.ca
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Child Health Update
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Child Health Update is produced by the
Pediatric Research in Emergency Therapeutics
(PRETx) program (www.pretx.org) at the BC
Pediatric Research in Emergency Therapeutics
Children’s Hospital in Vancouver, BC.
Dr Sakulchit is a member and Dr Goldman is Director of the PRETx program. The
mission of the PRETx program is to promote child health through evidence-based
research in therapeutics in pediatric emergency medicine.
  Do you have questions about the effects of drugs, chemicals, radiation, or infections
in children? We invite you to submit them to the PRETx program by fax at
604 875-2414; they will be addressed in future Child Health Updates. Published Child
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